EPLEX® RESPIRATORY PATHOGEN (RP) PANEL

Additional Manufacturer Narrative

THE INSTRUMENT'S SERIAL NUMBER IS (B)(6). THE ISSUE WAS CONSISTENT WITH A LOWER THAN INTENDED TARGET CONCENTRATION WITHIN THE SAMPLE VOLUME ANALYZED BY THE ASSAY. THIS LOT CONTAINS A RAW MATERIAL THAT HAS BEEN IDENTIFIED AS HAVING POTENTIAL FOR LEAKS. NO LEAKS WERE OBSERVED, HOWEVER SMALL AMOUNTS OF REAGENT MAY NOT BE VISIBLE. THIS ISSUE COULD NOT BE EXCLUDED BY THE INVESTIGATION. THE ISSUE IS ALSO CONSISTENT WITH LOW VIRUS TITERS THAT CAN RESULT IN THE DETECTION OF THE INFLUENZA A SUBTYPE WITHOUT THE INFLUENZA A MATRIX, DETECTION OF THE INFLUENZA A SUBTYPE WITHOUT THE INFLUENZA A MATRIX THAT CAN ALSO INDICATE THE PRESENCE OF A NOVEL STRAIN, AND FOR THE INFLUENZA A MATRIX AND SUBTYPE, THERE IS THE POSSIBILITY OF FALSE NEGATIVE VALUES DUE TO THE PRESENCE OF SEQUENCE VARIANTS IN THE VIRAL TARGETS OF THE TEST. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE EPLEX® RESPIRATORY PATHOGEN (RP) PANEL FOR 1 PATIENT SAMPLE ON AN EPLEX SYSTEM. THE PATIENT SAMPLE WAS TESTED 3 TIMES. IT WAS REPORTED THAT INFLUENZA A H3 WAS DETECTED DURING THE FIRST TEST, AND THERE WAS NO SIGNAL FOUND FOR THE INFLUENZA A TARGET. IT WAS REPORTED THAT FOR THE SECOND AND THIRD TESTS, NO INFLUENZA TARGETS WERE DETECTED EITHER TIME AND NO SIGNAL WAS IDENTIFIED IN THE DATA.